ProgesteroneCrinone
Luteal phase support as part of an assisted reproductive technology (ART) treatment cycle for infertile women.
Decisions on record
- Meeting Nov 2024 Recommended Menopausal hormone therapy
- Meeting Jul 2024 Recommended Luteal phase support for assisted reproductive technology
- Meeting Jul 2024 Noted Assisted reproductive technology
- Meeting Jul 2022 Recommended Infertility, luteal phase support in assisted reproductive technology treatment
- Meeting Nov 2021 Recommended Prevention of preterm birth
- Meeting Nov 2020 Recommended Prevention of preterm birth
- Meeting Nov 2020 Recommended Prevention of preterm birth
- Meeting Jul 2016 Recommended Assisted reproduction
2 earlier decisions
- Mar 2016 Not recommended Assisted reproduction
- Mar 2014 Recommended Endometrin® Ferring Pharmaceuticals Pty Ltd Assisted reproductive therapies To request a PBS listing as part of Section 100 IVF/GIFT Program for luteal phase support in patients who are receiving medical treatment as described in items 13200 or 13201 in the Medicare Benefits Schedule. The luteal pha
Access path
- TGA registered · Crinone
TGA label narrower than the PBS population
- Mar 2014Recommended
vs progesterone gel (Crinone) and progesterone pessaries…
- Mar 2016Not recommended
Cost-minimisation analysis not conducted against the appropriate comparator (should be progesterone pessary, the…
- ↻ resubmittedJul 2016Recommended · restricted
Comparator changed: progesterone pessary (progesterone 8% vaginal gel also considered) →…
- Nov 2020Recommended · restricted
Comparator changed: progesterone pessary (Oripro) → best supportive care (standard of…
- Nov 2020Recommended · restricted
Comparator changed: progesterone pessary (Oripro) → best supportive care (standard of…
- Nov 2021Recommended
Comparator changed: Standard of Care (SOC) → Utrogestan (progesterone 200 mg soft capsule)
- Jul 2022Recommended · restricted
Comparator changed: Utrogestan (progesterone 200 mg soft capsule) → Crinone 8% (90 mg)…
- Jul 2024Recommended · restricted
Comparator changed: Crinone 8% (90 mg) progesterone vaginal gel → progesterone capsule…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the Authority Required (STREAMLINED) listing of progesterone capsule 300 mg (Utrogestan) BID on the basis it should be available only under special arrangements covered under the PBS section 100 (IVF Program) for LPS as part of an ART treatment cycle.PSD · Jul 2024
6.2 The PBAC did not consider it appropriate to cost-minimise based on an equivalent price per day of treatment. The PBAC advised that the CMA should be calculated at an equivalent price per treatment course and noted that the sponsor accepted this in its pre-PBAC response.PSD · Jul 2024
5.21 As a Category 4 submission, the economic analysis has not been independently evaluated. 4PSD · Jul 2024
5.22 The submission presented a cost-minimisation approach (CMA) of progesterone capsule 300 mg BID compared with progesterone capsule 200 mg TID.PSD · Jul 2024
5.19 The submission claimed the non-inferior comparative effectiveness and non-inferior comparative safety of progesterone capsule 300 mg BID compared with progesterone capsule 200 mg TID.PSD · Jul 2024
5.20 The PBAC considered that the claim of non-inferior comparative effectiveness and non-inferior comparative safety was reasonable.PSD · Jul 2024
4.3 The requested amendment for a maximum quantity of 45 pessaries with 3 repeats for Oripro would reduce the number of patient co-payments from 6 to 4. Currently, the total co-payment costs for Oripro is $247.80 for 6 months of treatment (general patient) compared with $165.20 for a general patient on Utrogestan.PSD · Nov 2021
4.7 Based on the requested amendments to the Oripro (prevention of preterm birth) listing, the submission estimated there would be a net cost to the PBS/RPBS of $0 to < $10 million over six years. The loss in average co-payments per patient ($38.43) offsets the save from the reduction in DPMQ per patient (-$13.27). This results in a net cost per patient of $25.16 and hence the net cost to the PBS/RPBS of $0 to < $10 million over six years. 4PSD · Nov 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC could only recommend listing progesterone 300 mg at a higher price than the alternative therapy or therapies if it was satisfied that it provides, for some patients, a significant improvement in efficacy or reduction of toxicity over the alternative therapy or therapies (National Health Act 1953, Section 101(3B)). PBAC · 2024
Decision context
PopulationInfertile women undergoing assisted reproductive technology (ART) treatment cycles requiring luteal phase support, from embryo transfer until implantation confirmed by positive B-hCG measurement.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended · restricted | progesterone capsule 200 mg three times daily | — | Cost-minimisation · Cost-minimisation |
| Jul 2022 | Recommended · restricted | Crinone 8% (90 mg) progesterone vaginal gel | — | RCT · Clinical pregnancy |
| Nov 2021 | Recommended | Utrogestan (progesterone 200 mg soft capsule) | — | Cost-minimisation · Cost-minimisation |
| Nov 2020 | Recommended · restricted | best supportive care (standard of care) | — | Meta-analysis · Preterm birth |
| Nov 2020 | Recommended · restricted | Standard of Care (SOC) | — | Meta-analysis · Preterm birth |
| Jul 2016 | Recommended · restricted | progesterone pessary (Oripro) | — | Cost-minimisation · Cost-minimisation |
| Mar 2016 | Not recommended | progesterone pessary (progesterone 8% vaginal gel also considered) | — | RCT · Ongoing pregnancy at 12 weeks |
| Mar 2014 | Recommended | progesterone gel (Crinone) and progesterone pessaries (Oripro) | — | RCT · Ongoing pregnancy |
Consumer voice
No consumer comments were received for this item. Consumer comments received for Oripro are included in the separate Public Summary Document for Oripro.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to infertile women in ART cycles; TGA label includes support during pregnancy beyond luteal phase.